UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022172
Receipt number R000025546
Scientific Title Efficacy and safety of olanzapine suppositories in terminally ill patients with delirium or nausea and vomiting.
Date of disclosure of the study information 2016/05/02
Last modified on 2016/05/02 12:31:52

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Basic information

Public title

Efficacy and safety of olanzapine suppositories in terminally ill patients with delirium or nausea and vomiting.

Acronym

Efficacy and safety of olanzapine suppositories.

Scientific Title

Efficacy and safety of olanzapine suppositories in terminally ill patients with delirium or nausea and vomiting.

Scientific Title:Acronym

Efficacy and safety of olanzapine suppositories.

Region

Japan


Condition

Condition

delirium, nausea and vomiting

Classification by specialty

Medicine in general

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

A new formulation of olanzapine available for terminally ill patients with oral feeding difficulties is needed. Rectal administration using suppositories is an alternative for patients for whom administration via the oral route is not feasible. So, we prepare olanzapine suppositories and evaluate the clinical efficacy and safety of olanzapine suppositories used to treat patients with delirium, vomiting, or nausea.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Responses to olanzapine therapy are evaluated based on clinical assessments by physicians. Information about the side effects is extracted from the electronic medical records of each patient.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Patients use olanzapine suppositories as a treatment for delirium or nausea and vomiting at the time of oral feeding difficulties. Patients are administered 2.5 mg, 5 mg, and 10 mg of olanzapine suppositories.

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

We selected to treat for delirium or nausea and vomiting in terminally ill cancer patients with oral feeding difficulties.

Key exclusion criteria

We exclude children and patients with taking orally.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masayuki Miyazawa

Organization

Shonan Central Hospital

Division name

Pharmacy

Zip code


Address

1-3-43 Hatori, Fujisawa-si, Kanagawa, Japan

TEL

0466-36-8151

Email

miyazawa@swg.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masayuki Miyazawa

Organization

Shonan Central Hospital

Division name

Pharmacy

Zip code


Address

1-3-43 Hatori, Fujisawa-si, Kanagawa, Japan

TEL

0466-36-8151

Homepage URL


Email

miyazawa@swg.or.jp


Sponsor or person

Institute

Shonan Central Hospital

Institute

Department

Personal name



Funding Source

Organization

No

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Division of Practical Pharmacy, Keio University Faculty of Pharmacy

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2016 Year 05 Month 02 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2015 Year 01 Month 01 Day

Date of IRB


Anticipated trial start date

2015 Year 01 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 05 Month 02 Day

Last modified on

2016 Year 05 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025546


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name